Note: Descriptions are shown in the official language in which they were submitted.
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"Integrated device for the non-invasive personalised treatment of skin
blemishes and
associated multi-step method"
Description
Field of the art
The present invention regards the field of aesthetic and sports medicine as
well as
rehabilitation. In particular it describes a device suitable to recognize and
treat, by means of
compressive microvibration, some diseases such as cellulite, tissue
recompacting, lymphatic
and venous stasis, edematosis, muscle and cicatricial contractures, shoulder-
neck syndrome
and pubalgias. Other fields of application of this device are pre-post-surgery
treatments for
athletes, sports massage, lymphatic drainage and the treatment of pains of
various origins.
Prior art
The so-called cellulite, also called "gynoid lipodystrophy", "fibrous
oedematous
panniculopathy", "adiposis edematosa", "sclerotic fibrous oedematous
panniculopathy",
"dermopanniculosis deformans", "status protrusions cutis, and "liposclerosis",
is a
topographical manifestation of the skin associated with depressions or
introflections frequent
in pelvic and abdominal areas, hips, glutei and thighs. It may also manifest
itself associated
with nodules in subcutaneous adipose tissue and, in rare cases, with a
suspected
inflammatory condition.
The great confusion about the name to give to cellulite reflects the
difficulty of correctly
understanding the nature of the phenomenon. Despite the great interest in the
treatment of
this condition and the huge market for topical treatments aimed at improving
its appearance,
cellulite is still an enigmatic condition for medical researchers.
The high incidence (80-90%) in the female population presenting cellulite
blemishes in post
pubertal age, in addition to the fact that it occurs without symptoms, makes
it to be
considered a normal physiological condition. It can instead be considered in a
pathological
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framework pointing out that whereas it is true that it is a normal condition
for many women,
it does not apply to all, and that in its most serious forms it manifests
itself with nodules
painful to palpation which lead to suspicion of inflammatory processes.
Furthermore, it is
generally associated with an excessive accumulation of subcutaneous adipose
tissue whose
relationship with cardiovascular risk is unclear.
Dozens of different causes have been hypothesised, including: metabolism
disorders,
nutritional disorders, specific subcutaneous architectures, alterations of
connective tissue
structure, hormonal factors, genetic factors, microcirculatory system
disorders, alterations in
the lymphatic system, alterations in the extracellular matrix, inflammations.
Cellulite classifications are as follows:
- oedematous: i.e. associated with an accumulation of liquids, especially
around ankles,
calves, thighs and arms.
- fibrous: i.e. associated with an increase in trabecular structures and
connective tissue
septa which divide the subcutaneous adipose tissue into various lobes; fibrous
cellulite is
characterised by small nodules that are not perceivable to the touch except as
a
subcutaneous roughness and by the orange peel-like skin.
- sclerotic: i.e. associated with a hardening of the tissues associated
with large nodules and
plaques; this form can be very painful.
Various measures can help prevent cellulite. Some attention in nutrition,
constant physical
activity, the use of comfortable and not too tight clothes, shoes with not too
high heels and
changes in posture are the easiest remedies to implement to prevent this
annoying disorder.
The huge market of treatments for reducing cellulite ranges from topical
products to
liposuction. However, many of these treatments lack evidence of effectiveness.
Below is a
list of the most common ones:
= topical products i.e. creams and the like to be applied manually on the area
in question
constantly and on daily basis for long periods of time;
= massages;
= pressure therapy: treatment based on the external pressure of the
patient's limbs or the
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abdominal area thereof through a specific apparatus;
= mesotherapy: a technique for the administration of drugs through the
intraepidermal,
superficial and deep intradermal and subcutaneous or hypodermic routes, has
the
advantages of being suitable for reducing doses of active ingredient which
have a
prolonged effect over time;
= emulsion-lipolysis: a pharmacological therapy which can be carried out by
means of a
regional injection with hypothalamic phospholipids, carnitine, aminophylline,
lidocaine 2%, saline solution;
= lipoapoptosis: a pharmacological therapy that can be carried out by means
of a
regional injection with vitamin C, trivalent iron, lidocaine 2%, water for
injectable
preparations;
= carboxytherapy: treatment that originates from thermal medicine and
consists in the
administration of carbon dioxide through the subcutaneous route;
= osmotic lipoclasia: cutaneous biostimulation with platelet-rich plasma;
= oxygenoclasia: technique for introducing pure medical oxygen into the excess
fat
through a small needle;
= endermologie system: a technique designed in France in the 70s in which a
vacuum
system and a plurality of rollers, mounted on a handpiece, exert pressure and
lifting
actions on the skin causing a redistribution of subcutaneous fat.
= ultrasound therapy: treatment based on the effect produced by mechanical
vibrations
applied to the outer tissues of the body by means of an ultrasonic transducer.
= laser therapy: treatment that acts at various levels of depth based on
the power of the
transmitted rays.
= diathermy: a practice, without scientific validation, which supports
curative properties
induced by the increase in the temperature of some non-superficial areas of
the body
caused by the passage of electric current.
As observable from the list above, which is not exhaustive, the market is
saturated with
treatments, among which there are some without sure results. Ineffectiveness
is often due to
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the fact that, as explained above, the cause of cellulite and of the disorders
it entails remain
unclear.
There are also various patents claiming treatments for cellulite care such as
US 2002147467
which provides for, first of all, an exfoliating treatment to maximize the
absorption of the
substances applied to the skin, then the administration of mechanical
vibrations associated
with electric pulsations in the area in question.
EP 1844750, on the other hand, claims an instrument for aesthetic treatments,
therefore not
of medical nature, which reduces cellulite through ultrasonic vibrations with
a frequency
between 25 kHz and 50 kHz.
GB 2303552 discloses a medical apparatus capable of reducing cellulite through
ultrasounds
at a frequency of about 3.3 MHz reaching a depth of 1.27 - 2.54 cm from the
skin surface
without overheating the part.
The worldwide patent, W02007122656, owned by Fenix 5.r.1., a market leader in
anti-
cellulite and anti-blemishes therapies as well as skin disorders in general,
claims a computer-
controlled vibratory device, used to treat parts of the body, the whose
primary characteristic
is to apply massages by inducing mechanical oscillations by means of a
plurality of massage
elements which are rotatably mounted about their own axis in a roller driven
by an electric
motor. The rotation of the roller around the shaft thereof is controlled by
the operator
through an electronic control unit, by selecting a program suitable for the
treatment to be
carried out. The device described in this patent performs a massage based on
the resistance
opposed by the muscles located under the adipose layer.
An object of the present invention is to provide a device and a compressive
microvibration
method customised on the disorders suffered by each patient, which performs
four actions
synergistically by acting on the vascular system at the microcirculation
level, on the
lymphatic system, on the tissue re-compaction and on the analgesic effect,
thus also entailing
a muscular effect. The operation of this device relies on a sensor capable of
detecting the
type of disorder and a dedicated software that determines the best therapy to
be followed
case by case.
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Description of the invention
According to the present invention, a device is provided and a method of use
associated
thereto that effectively overcomes the aforementioned drawbacks is described.
Advantageously, the device integrates handpieces to perform different
treatments to be
5
modulated depending on the disorder suffered by each patient. The treatment is
particularly
effective on muscle contractures, cellulite, stretch marks, wrinkles and more.
The device
comprises a portable console provided, at the upper part, with a plurality of
recesses each
suitable to house a corresponding handpiece.
The device comprises at least 3 handpieces and possibly a fourth additional
handpiece. Said
handpieces are the following:
- A first handpiece suitable for performing a percussion treatment on the body
and/or
face of a patient by means of a rotor comprising a plurality of rotating
elements
installed on a corresponding plurality of semi-axes installed equally spaced
on the
circumference of a ring nut. The rotor is included in a head of the handpiece,
which
has an opening protected by an elastic membrane designed to allow the
percussion
to be carried out, avoiding direct contact between the rotating elements and
the
patient's epidermis. Included in the handle of the handpiece, consisting of
two half-
handles suitable to be mutually engaged in this case, is the electric motor
which
controls the percussion frequency of said rotor. Said first handpiece is
therefore
advantageously suitable cause a microtrauma at the wrinkle furrow, thus
facilitating
the natural recovery and therefore a reduction of the wrinkle depth or of the
stretch
on which the percussion is applied.
Furthermore, in the preferred embodiment said first handpiece has a movable
head,
tilted according to an angle of 100, provided with a spot laser and a micro-
camera.
- A second handpiece suitable for carrying out an ablative micro-vibration
treatment
on the patient's body, also obtaining an exfoliating effect. This object is
achieved
by means of a rotor comprising a plurality of rotating and vibrating elements
suitable to vibrate and rotate in a converging or diverging direction with
respect to a
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median axis, according to the arrangement of a plurality of pins on which said
rotating elements are fitted. The median axis of the rotor is occupied by a
middle
ring nut on which the operator can advantageously act to cause said rotating
elements to impart a converging or diverging force on the patient's skin. The
rotor
is inserted into a shell provided with an open side, which allows the contact
between said rotating elements and the body of said patient, and with a closed
side
facing the operator, comprising a pair of light indicators suitable to signal
the
converging or diverging direction of the rotating elements to the operator.
The rotor
is connected beneath an electric motor, integrated in the handle of the
handpiece,
which determines the frequency of rotation and vibration of the rotor. Said
second
handpiece is therefore advantageously suitable to expand or compact the skin
tissue
by alleviating blemishes such as wrinkles, stretch marks and scars, thus also
obtaining an exfoliating effect, referred to as "stretching" in the technical
jargon. In
the preferred embodiment of the present invention, this exfoliating effect is
obtained
by a surface treatment of the outer surface of each rotating element which has
a
predetermined roughness and density, or softness.
- A third handpiece suitable for performing a compressive micro-vibration
treatment
on the face of a patient by means of a rotor provided with rotating elements
suitable
to vibrate and rotate around a plurality of pins which extend from an upper
ring nut
to a lower ring nut. The rotor is inserted into a shell provided with an open
side,
which allows the contact between said rotating elements and the body of the
patient,
and with a closed side facing the operator, provided with a light pressure
indicator
which signals, to the operator, the pressure with which he/she is pressing on
the
patient's face. Also in the case of the third handpiece, the rotor is driven
by an
electric motor integrated in the handle. Thus, said third handpiece is
advantageously
suitable to expand the pores of the patient's epidermis.
- A fourth handpiece, present only optionally with respect to the device of
the
invention, suitable for carrying out a treatment for the vibro-transportation
of active
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ingredients in depth on the body and/or face of a patient by means of a
vibrating
head suitable to vibrate, at a predetermined frequency driven by an electric
motor
integrated in the handle of the handpiece. Optionally, said fourth handpiece
also
comprises an active ingredient reservoir suitable to release the desired
amount of
cream, gel, or mousse on the patient's body upon pressing a special key by the
operator. Using the fourth handpiece following the application of at least one
of the
first three handpieces allows an in-depth penetration of the desired active
ingredient, which would otherwise be achievable only by injection, making the
treatment non-invasive, painless, and at least equally effective.
All said handpieces are power-supplied by special electrical cables which
connect them to
said console. They can also be easily disconnected by operating special
connection means
which connect the distal ends of said power supply cables to the electric
motors included in
said handpieces.
Each handpiece also advantageously includes a rotation and vibration
adjustment device and
an electric energy absorption sensor. The latter is suitable to detect the
amount of electric
energy absorbed by each handpiece in order to obtain the desired rotation and
vibration of
the corresponding rotors, communicating the detected data to a control unit
programmed
with a dedicated software. By processing the data coming from said electric
energy
absorption sensor, the control unit acts, in real time, on the frequency
adjustment devices of
the handpiece in order to obtain an immediate variation of the rotation and
vibration
frequency of said rotors, within a pre-established range comprised between 20
Hz and 700
Hz, preferably between 40 Hz and 355 Hz, depending on the mechanical strength
provided
by the skin tissue of the patient at contact with the handpiece in use.
This device constitutes the main advantage offered by the present invention,
given that the
operator is greatly facilitated in the work thereof by the possibility of
automatically and
immediately identifying and modifying the intensity of the treatment in areas
affected by
different muscle contractures or tissue disorders.
All the data relating to the therapy in progress are displayed and can be
modified manually
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by the operator through a communication interface, preferably integrated in
said console.
More in detail, the method of use of the device according to the present
invention consists of
the following steps:
- setting the parameters, through said communication interface, based on
the
characteristics of the patient's tissue, the age and musculature thereof;
- a test, in which, by gripping a handpiece and placing the relative rotor
at contact
with the patient's body or face, the relative electric energy absorption
sensor sends
the detected data to the control unit integrated in the treatment device. By
comparing the electric energy absorption data and the data of the vibrations
and
rotations frequency set by the operator, through the communication interface,
the
control unit communicates to the operator the correctness or incorrectness of
the
frequency range of the vibrations and rotations set;
- administering the therapy, in which the operator covers the areas of the
patient's
body or face to be treated with a handpiece at a time according to a sequence
pre-
established by the type of treatment. In the preferred embodiment, the
recesses in
which the handpieces are housed are advantageously provided with means for
retaining said handpieces suitable for releasing the handpieces only in the
order pre-
established by the therapy being carried out. During the treatment, the
operator
applies a predetermined pressure perpendicular to the skin tissue of the
patient and,
should the electric energy absorption sensor, possibly combined with a
pressure or a
motor revolutions sensor, of the handpiece in use, detect an area of greater
mechanical strength, for example a muscle contracture, said control unit,
which
processes the data sent by said electric energy absorption sensor, sends a
command
to increase the vibrations and rotations frequency to the frequency adjustment
device of the handpiece in use, until a lower mechanical resistance is
detected.
- At the end of therapy, in a fourth step of monitoring the homogeneity of
the
treatment on the area affected by the skin disorder or blemish, the operator
examines the reddening of the skin due to the vascularization of the tissue
induced
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by the treatment, so as to ensure that each area of the body or face has been
treated
uniformly. A more scientific version of this final step of the method of use
of the
machine provides for the presence of a temperature sensor for each handpiece,
suitable to communicate, to the control unit of said device, the temperature
variation
of the skin tissues of the patient from the beginning of the treatment.
Other embodiments of the device which make it even more advantageous both in
terms of
efficiency and comfort for the operator and the patient, provide for the
presence of at least
one of the following devices:
- a resistor inside said handpieces, suitable to heat the portion of the
handpiece which
is at contact with the patient's body or face, up to a predetermined
temperature;
- a resistor inside the recesses suitable to heat the corresponding
handpieces before
they are placed at contact with the patient's body or face;
- a device for disinfecting the handpieces by means of a common infrared
lamp.
Lastly, the rotating elements of the handpieces can consist of balls, ovoids
or cylinders,
preferably balls, arranged honeycomb-like or V-like manner, made of anti-
allergy silicone or
gel of hardness comprised between 5 shore and 100 shore, preferably 35 shore.
In a variant embodiment of said rotating elements (balls) the effects of the
treatment
described so far, already very advantageous, are added to the further
beneficial effects of the
"micro-vacuum" by virtue of the fact that the outer surface of said rotating
elements is
provided with a plurality of spherical cap-shaped recesses suitable to create
a suction effect
when pressed onto the patient's epidermis.
The advantages provided by the present invention will be clear in light of the
description
outlined up to now. Furthermore, they will be more apparent due to the
attached figures and
relative detailed description.
Description of the figures
The invention will be described hereinafter in at least one preferred
embodiment, provided
by way of non-limiting example, with reference to the attached figures,
wherein:
- FIGURE 1 shows a three-dimensional view of the device in a three-recess
embodiment
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1.1-1.2-1.3. Also shown is the fourth handpiece 7, optionally present.
- FIGURE 2(a) illustrates an exploded view of the first handpiece 2.
- FIGURE 2(b) shows, in detail, an exploded view of the rotor 2.11 of the
first handpiece 2.
- FIGURE 3(a) shows an exploded view of the second handpiece 2.
5 .. - FIGURE 3(b) shows a three-dimensional view of the rotor 3.10 of the
second handpiece 3.
- FIGURE 3(c) shows an exploded view of the aforementioned rotor 3.10.
- FIGURE 4(a) illustrates an exploded view of the third handpiece 4.
- FIGURE 4(b) shows an exploded view of the rotor 4.9 of the third
handpiece 4.
- FIGURE 4(c) shows an exploded view of the shell 4.4 of the third
handpiece 4.
10 - FIGURE 4(d) shows a three-dimensional view of the aforementioned rotor
4.9.
- FIGURE 5 shows an exploded view of the fourth handpiece 7.
Detailed description of the invention
Now, the present invention will be illustrated purely by way of non-limiting
or non-binding
example, with reference to the figures illustrating some embodiments regarding
the present
inventive concept.
With reference to FIG. 1, shown in its entirety is the device subject of the
present invention
in which there is a portable console 1 containing a control unit (not visible)
provided with a
communication interface 5 and with three recesses 1.1-1.2-1.3, preferably
heated, each of
which is suitable to house a corresponding handpiece 2-3-4.
.. Depending on the patient's disorder, the operator selects a vibrations and
rotations frequency
range that the rotors 2.11-3.10-4.9 of the handpieces 2-3-4 will perform when
placed on the
patient's skin.
The correctness of such range is verified immediately by virtue of the fact
that each
handpiece 2-3-4 is provided with electric energy absorption sensor which
communicates the
detected data suitable to detect the amount of electric energy suitable to
communicate the
detected data to said control unit programmed with a dedicated software
suitable to process
the data coming from said electric energy absorption sensors, possibly
combined with
pressure or motor revolutions sensor, and to consequently act, in real time,
on the frequency
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adjustment devices of each handpiece 2-3-4 in order to obtain an immediate
variation of the
rotation and vibration frequency of said rotors 2.11-3.10-4.9, within a pre-
established range
comprised between 20 Hz and 700 Hz, preferably between 40 Hz and 355 Hz,
depending on
the mechanical strength provided by the skin tissue of the patient at contact
with one of said
handpieces 2-3-4;
Subsequently, the operator can proceed with the therapy by covering the areas
of the
patient's body or face to be treated with a handpiece 2-3-4 at a time, for a
pre-established
time interval, applying a predetermined pressure perpendicular to the
patient's skin tissue. In
the recesses 1.1-1.2-1.3 of the console 1, there are retention means which
release the
handpieces 2-3-4 only in the order pre-established by the therapy being
carried out,
preventing any possibility of error.
Each handpiece 2-3-4 has a rotor 2.11-3.10-4.9 consisting of rotating elements
2.11.4-3.10.5-
4.9.5 or balls arranged in a honeycomb-like or V-like manner, made of anti-
allergy silicone
or gel with a hardness equal to 35 shore.
In greater detail, the first handpiece 2 is suitable to perform a percussive
treatment on the
patient's body and/or face. The balls 2.11.4 of the rotor 2.11 are installed
on a corresponding
plurality of semi-axes 2.11.2 equally spaced on the circumference of a ring
nut 2.11.1. The
rotor 2.11 is installed between a movable head which allows the movement of
the membrane
2.2 and an angular support 2.5. Said head 2.2 is provided with an elastic
membrane suitable
to allow the execution of the percussion preventing the direct contact between
the balls
2.11.4 and the epidermis of the patient. The angular support 2.5, on the other
hand, is fitted,
by means of a suitable insert 2.6 on an electric motor 2.7 which controls the
percussion
frequency of said rotor 2.11, power-supplied by a special cable, connected
through common
connection means 2.8, connected to said console 1. The angular support 2.5,
the insert 2.6,
the electric motor 2.7 and the connection means 2.8 are arranged in a pair of
half-handles
2.9-2.10, which are suitable to engage each other so as to constitute the grip
handle of said
first handpiece 2.
The second handpiece 3, is suitable for carrying out an ablative micro-
vibration treatment on
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the patient's body. The balls 3.10.5 of the rotor 3.10 vibrate and rotate in a
convergent or
divergent direction according to the arrangement of a plurality of pins 3.10.9
into which the
balls 3.10.5 are fitted. More in detail, said pins 3.10.9 extend from an upper
ring nut 3.10.2
to a middle ring nut 3.10.4 and from said middle ring nut 3.10.4 to a lower
ring nut 3.10.6.
The rotation of said middle ring nut 3.10.4 by said operator modifies the
configuration of
said pins 3.10.9 in order to cause the balls 3.10.5 to converge or diverge
toward or from said
middle ring nut 3.10.4. The rotor 3.10 rotates around an upper semi-axis
3.10.3 and a lower
semi-axis 3.10.8 and it is inserted into a shell 3.4 provided with an open
side and a closed
side. The open side allows contact between the balls 3.10.5 and the patient's
body while the
closed side is directed toward the operator and comprises a pair of light
indicators 3.3
suitable to signal to the operator the converging or diverging direction of
the balls 3.10.5 on
the patient's body. The rotor 3.10 is connected, at the upper part by means of
a pin 3.10.1, to
a bearing 3.2 and lastly to an upper plug 3.1 of the second handpiece 3. At
the lower part, on
the other hand, the rotor 3.10 is connected to an electric motor 3.5,
integrated in the handle
3.6, power-supplied by a special cable, connected by common connection means
3.7
included in a lower cap 3.8.
The third handpiece 4, is suitable for carrying out a compressive micro-
vibration treatment
on the patient's face. The balls 4.9.5 of the rotor 4.9 vibrate and rotate
around a plurality of
pins 4.9.4 which extend from an upper ring nut 4.9.2 to a lower ring nut
4.9.6. The rotor 4.9
rotates, at a pre-established frequency, around a rotation axis 4.9.3 and it
is inserted into a
shell 4.4 provided with an open side and a closed side. The open side allows
the contact
between said balls 4.9.5 and the body of said patient; the closed side is
directed toward the
operator and it comprises a light pressure indicator 4.4.1 suitable to signal,
to the operator,
the pressure with which he/she is pressing the handpiece 4 on the patient's
face. The rotor
4.9 is connected, at the upper part by means of a pin 4.9.1, to a bearing 4.2
and lastly to an
upper cap 4.1, whereas at the lower part it is connected, by means of a joint
4.9.7, to an
electric motor 4.6, integrated in a handle 4.5, power-supplied by a special
cable connected
through common connection means 4.8 included in a lower cap 4.7.
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At the end of the treatment, the operator verifies whether each tissue was
treated
homogeneously by monitoring the increase of skin temperature, due to the
vascularization of
the tissue induced by the treatment, performed by the control unit which
processes the
temperature data detected by a temperature sensor of the handpiece 2-3-4 in
use.
Lastly, it is clear that the invention described up to now may be subjected to
modifications,
additions or variants obvious to a man skilled in the art, without departing
from the scope of
protection outlined by the attached claims.
